Deferasirox BID (Twice a Day) in Transfusion Dependent Thalassemia Patients With Inadequate Response to High Doses

Inclusion Criteria: * Written informed consent must be obtained prior to any screening procedures * Male or female aged ≥ 2 years at screening * Patients with transfusion dependent thalassemia * Patients confirmed as inadequate- responders to deferasirox \> 35 mg/kg QD and treated with QD for at least 6 months * Regular transfusion indicated by a blood requirement ≥ 8 blood transfusions per year at screening * Serum ferritin level \> 2,500 ng/mL at screening (two consecutive values at least 2 weeks apart from each other) * One SF measurement \> 2,500 ng/mL between 6 and 9 months prior to study enrollment * Three SF measurements \> 2,500 ng/mL, performed at least 3 weeks apart from each other, during the 6 month treatment with QD dosing of deferasirox prior to study enrollment * The average of the two screening SF values (collected 2 weeks apart from each other) must not show a decrease from the 6 to 9 month SF value taken prior to study enrollment * The average of the two screening SF values (collected 2 weeks apart from each other) must not show a decrease from each of the three SF values obtained during the 6 months of deferasirox QD treatment prior to study enrollment * LIC ≥ 7 mg Fe/g dw measured at the screening visit, (this value will be used as a baseline measurement Exclusion Criteria: * Patients who are intolerant to \> 35 mg/kg/day QD of deferasirox in the 6 months prior to study enrollment * Patients with mean levels of ALT \>5 x ULN * Patients with serum creati…